Summary of adverse events for the phase IIa and phase IIb trials. Data are n (%) unless otherwise indicated.
| Phase IIa | Phase IIb | Phase IIb Toreforant | |||||
|---|---|---|---|---|---|---|---|
| Placebo | Toreforant, 100 mg | Placebo | 3 mg | 10 mg | 30 mg | Combined, 30 mg* | |
| Safety population, n | 28 | 58 | 68 | 67 | 68 | 68 | 87 |
| Patients with AE | 14 (50) | 34 (59) | 45 (66.2) | 39 (58.2) | 42 (61.8) | 40 (58.8) | 46 (52.9) |
| Common AE (≥ 5% of patients) | |||||||
| Nasopharyngitis | 1 (4) | 3 (5) | 7 (10.3) | 2 (3.0) | 5 (7.4) | 8 (11.8) | 8 (9.2) |
| Urinary tract infection | — | — | 2 (2.9) | 4 (6.0) | 4 (5.9) | 5 (7.4) | 5 (5.7) |
| Bronchitis | — | — | 2 (2.9) | 4 (6.0) | 3 (4.4) | 4 (5.9) | 4 (4.6) |
| Diarrhea | — | — | 1 (1.5) | 2 (3.0) | 1 (1.5) | 8 (11.8) | 8 (9.2) |
| Arthralgia | 1 (4) | 6 (10) | — | — | — | — | — |
| Back pain | 0 | 4 (7) | — | — | — | — | — |
| RA, possible flare/worsening | 1 (4) | 3 (5) | — | — | — | — | — |
| Nausea | 0 | 3 (5) | — | — | — | — | — |
| Patients who died | 0 | 1 (2) | 0 | 0 | 0 | 0 | 0 |
| Patients with SAE | 1 (4) | 6 (10) | 5 (7.4) | 3 (4.5) | 5 (7.4) | 2 (2.9) | 2 (2.3) |
| SAE occurring in > 1 patient | 1 (4) | 2 (3) | — | — | — | — | — |
| AE affecting dosing in phase IIa**/leading to study agent discontinuation in phase IIb | 4 (14) | 6 (10) | 5 (7.4) | 6 (9.0) | 3 (4.4) | 3 (4.4) | 3 (3.4) |
| AE occurring in ≥ 1 patient | — | — | 1 (1.5) | 2 (3.0) | 1 (1.5) | 0 | 0 |